MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 26920

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 07/26/2022

Event Type  Injury  

Event Description

Eminent clinical study: it was reported that in-stent restenosis and thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in right distal superficial femoral artery (sfa) involving proximal popliteal artery (ppa) with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilatation followed by placement of a 6 mm x 100 mm study stent.Following, post dilation, final stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1271 days post index procedure, subject presents to emergency department because of acute pains in the right leg, also complaints that the foot looks since pains started and it is cool, which is persisting when sitting.On the same day, pulse examination revealed cfa+, pa -, pta -, ata -, and dpa -.The subject was hospitalized on the same day for further treatment and evaluation.Ultrasound examination on the same day revealed suspected stent stenosis in the right popliteal artery.Event was also treated medically, and the subject was recommended to undergo surgery and revascularization as treatment for this event.On (b)(6) 2022, 1271 days post index procedure, to treat 100% stenosis in right ostial to distal sfa involving ppa with 120 mm long lesion length and a reference vessel diameter of 5 mm was treated by femoral bifurcation tea (thromboendarterectomy) was performed by dissection and retraction of the common femoral artery as well as the origins of the superficial and deep femoral arteries.Later, they were unclamped and longitudinal arteriotomy was performed at the proximal section of the common femoral artery reaching up to 2 cm into the proximal section of the sfa.Also, the cylinder[intima] on the middle section of the common femoral artery was underrun with the overhold clamp and severed.Using the ring stripper and monitored by an image converter, the [intima] cylinder was eluted beyond the stent up until the middle section of the popliteal artery in an antegrade direction and gradually recovered.No significant back flow was noted.Additionally, dsa of the right leg arteries performed revealed severe in-stent stenosis.For the same, angioplasty was performed using the balloon catheter in the size 5 x 120 mm.The stenosis was no longer able to be detected in the follow-up angiography.The sheath was removed, and the proximal section of the common femoral artery was unclamped with the 120 degree clamp.A non-boston scientific biologic bovine patch 8 mm x 80 mm was finally sewn in-place with 6-0 prolene using the continuous suture technique.Post procedure, no complications were noted resulted into 0% stenosis and no thrombus was also seen.Post operative, abi showed 0.91 at left and peripheral pulse was palpable.On (b)(6) 2022, the event was recovered/resolved.On (b)(6) 2022, the subject was discharged with the recommendation of aspirin for lifetime and clopidogrel for 6 weeks and advice for a follow up.

Manufacturer Narrative

Age at time of event: 64 years old at the time of study enrollment.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16147530
• MDR Text Key: 307188082
• Report Number: 2124215-2022-56428
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0022759071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Race: White